An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiFormTM pMDI vs Fluticasone pMDI plus Formoterol DPI in adolescent and adult subjects with mild to moderate-severe persistent, reversible asthma.

Mundipharma Research Limited0 个研究点目标入组 200 人开始时间: 2007年7月6日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Mundipharma Research Limited
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
•2. Known history of mild to moderate-severe persistent, reversible asthma for = 6 months prior to the screening visit.
•3. Demonstrate a FEV1 of =40% to =85% for predicted normal values (Quanjer et al, 1993) during the screening phase following appropriate withholding of asthma medications (if applicable).
•- No ß2-agonist use on day of screening.
•- No use of inhaled combination asthma therapy on day of screening.
•- Inhaled corticosteroids are allowed on day of screening.
•4. Documented reversibility of =15% in FEV1 in the screening phase.
•5. Demonstrate satisfactory technique in the use of the study medications.
•6. Willing and able to enter information in the diary and attend all study visits.
•7. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
•8. Written informed consent obtained.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Near fatal or life-threatening (including intubation) asthma within the past year.
•2. Hospitalisation or an emergency visit for asthma within the past year.
•3. History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
•4. History of omalizumab use within the past 6 months.
•5. History of leukotriene receptor antagonist use, e.g. montelukast or theophylline, within the past week.
•6. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac dysrhythmia. ‘Clinically significant’ is defined as any disease that, in the opinion of the investigator, would put the patient at risk through study participation or which would affect the outcome of the study.
•7. In the investigator's opinion, a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
•8. Significant, non-reversible, active pulmonary disease (e.g. chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
•9. Known Human Immunodeficiency Virus (HIV)-positive status.
•10. A smoking history equivalent to 10 pack years” (i.e. at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year etc.).
•11. Current smoking history within 12 months prior to the Screening Visit.
•12. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
•13. Subjects who have taken ß-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
•14. Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
•15. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
•16. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
•17. Current participation in a clinical study.

研究者

发起方

Mundipharma Research Limited

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